Public Comments
Comments provided on: July 30, 2019
Comments provided to: Food and Drug Administration
Language: English
Committing to diversity, equity and inclusion: A call to action for clinical trials
Publication
Published on: November, 19, 2020
Published in: PhRMA The Catalyst
MRCT Center Leaning In webinar: Data Standards and Analysis
Webinar
Presented on: January 13, 2021
Presented at: MRCT Center Leaning In Webinar Seriess
Webinar
Related Resources
See related Webinars, maintained on our project specific Diversity, Inclusion, and Equity in Clinical Research website:
October 14, 2020: Community Awareness, Access, Knowledge
October 28, 2020: Workforce Development
November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility
December 9, 2020: Study Conduct (Recruitment, Retention)
January 13, 2021: Data Standards and Analysis
January 27, 2021: Stakeholder Roles and Responsibilities
May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation
June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research
July 14, 2021: Simplifying the Complexity of Translation in Clinical Research
IRR: Implementing a Robust, Scalable Participant Data Return Solution
Case Study
Released on: March 27, 2023
Description: This case study outlines how an industry sponsor designed an initiative to return clinical trial data to participants.
IRR: Supporting Participant Decision-Making in Genetic Testing Studies
Case Study
Released on: March 27, 2023
Description: This case study shares an example of how one institution created an educational tool to support decision-making for potential participants in a genetic testing study.
Related Resources:
IRR Roadmap by Role.
IRR: Returning Routine Lab Results to Participants During a Clinical Trial
Case Study
Released on: March 27, 2023
Description: This case study demonstrates how an industry sponsor operationalized returning routine laboratory results to participants during an ongoing, multi-site clinical trial.
Related Resources:
IRR Roadmap by Role.
IRR: Responsibly Returning Secondary Findings
Case Study
Released on: March 27, 2023
Description: This case details the experience of a research team returning secondary findings to participants in a genetic testing study.
Related Resources:
IRR Roadmap by Role.
MRCT Center Post-Trial Responsibilities Definitions
Ethical Considerations for Clinical Investigations of Medical Products involving Children: Guidance for Industry, Sponsors, and IRBs
Public Comment
Comments provided on: December 20, 2022
Comments provided to: Food and Drug Administration re: Docket No. FDA-2022-D-0738
Dr. Bierer discusses Diversity in Clinical Research on the Clinical Trials Guru podcast
Podcast
Achieving Diversity, Inclusion, and Equity in Clinical Research A link to the guidance document: https://mrctcenter.org/diversity-in-clinical-research/